AstraZeneca Opens Up on PAT

Ziggy Waraszkiewicz, one of AstraZeneca's key PAT stewards, gave the "industry perspective" on PAT implementation and exploitation at the recent Pittcon show. He and his colleague Nils-Erik Andersson share their views.

One of the more vocal firms of late about its PAT programs and applications has been AstraZeneca. At last months Pittcon show in Orlando, and entire session devoted to PAT development and implementation was dominated by AZ presenters.

One of the companys resident PAT gurus, Ziggy Waraszkiewicz, delivered what he called an industry perspective on PAT. AstraZeneca, Waraszkiewicz says, has moved beyond the exploratory phase of PAT and is entering the exploitation phase.

He agreed to share a few thoughts with Pharmaceutical Manufacturing.

PM: What is your "industry perspective" on PAT? What two or three things are you seeing these days? What critical issues are being overlooked by industry and regulators?

Z.W.: The toughest challenge the scientists, familiar with the benefits of PAT in the pharmaceutical industry, face is not the science or the technology, but to convince the senior leadership to approve funding for PAT initiatives. Senior leadership, in many cases, is reluctant to fund products without a business case showing the return on the investment.

Emil Ciurczak [NIR expert, former research fellow at Purdue Pharma] recently stated in a review of this year's IFPAC Conference: "The wrong people come to these meetings. . . it is preaching to the choir . . . The financial officers of the companies often have no idea of why and what PAT is."

I feel many in the pharmaceutical industry still do not realize that whether you call it PAT, process understanding, war on variability, or continuous improvement, the expectation of the FDA in the future will be that the pharmaceutical industry, like many other complex industries, must fully understand and control their manufacturing processes.

PM: Where is PAT headed in the next year or two from an industry perspective? What, if anything, is holding it back?

Z.W.: Until the FDA and the industry begin disclosing, in a public forum, detailed examples of approved regulatory submissions which utilize PAT in making quality decisions, the industry will remain reluctant to risk regulatory approval delays by including PAT in the submission.

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